with regards to the interim trigger, the only change was the wording of "first half of 2014" to "middle of 2014". So, if you want, you can interpret it as the patients living slightly longer? however, i don't think we can say which arm is living longer. could be control or treatment or a mix of both. what we do know is the change from expectation is not large so i would assume the event is still occurring within the company's expectation. but if you like the think this change is due to the control arm living longer, that's just fine too.
zoom, the only thing that changed is that we know know when the analysis well be done... where as b/f we only knew when the analysis was to be made (i.e. when the 235 deaths were expected to occur). the company has been consist in projecting the event to occur around the middle of 2014 and that has not changed.
you make a good point, maybe there's a black out that will prevent insiders from selling even with the lock up exp. but then again, there's a lot of grey area to what constitute insider info? is knowing the event rate considered insider info? how about general conversations with the FDA? how about knowing raw cupid 1 data that was not published? how about seeing first hand the benefits experience by patients? some things are black and white like unpublished financials or partner discussions or buy out negotiations. other stuff like overall mood of the company, opinions and enthusiasm of the scientists who developed the drug, of the investigators excitement, or knowing the number of events are not so clear cut. since non of this is material info but at the same time this is not information people outside the company would get access to. what do you think?
odon thinks insiders will be selling like rats jumping off a sinking ship. insiders know better than any of us if cupid 1 was a mirage, if events in cupid 2 are tracking cupid 1 results, if mydicar will be approved w/ cupid 2 data and if cldn is steal at current price.
how much of an event come end of july will be a testament to how much insiders believe in mydicar b/c there will be a lot of insiders with a lot of options to buy at $1.12. If insiders don't sell than that's going to send a strong signal to the market and we could be warming ourselves from a nice bonfire courtesy of burning shorts.
swing, how many of your prediction has come true? yeah, that's right, NONE. knowing that you expect lock up exp to be a major event, i'm sure it'll be a NON event. seeing that you're still here making predictions, you must not put any money behind any of them huh? or else you've be broke by now and instead of posting on message boards, you'll be at a some corner crying yourself to sleep... boo hoo hoo.
i expect extreme vol to continue up until april when cupid 2 data is released and then we're going to see the biggest pop in biotech history when it's announced that cupid 2 replicated cupid 1 results. while we cldn longs are jumping up for joy; the clowns over at ssh will still be slapping each other on the back saying some day ssh is going to have a pop just like that... some day and the curtain falls on those clowns as their investment disappears into nothing.
bev, you must not have any experience working in wall street or at the front office or with market makers? the fact that you think taking a course in investing can prepare you for the games being played in the market tells me you're an amateur and a probably get all excited about making a few thousand trading. i don't need school the teach me what life has already prepared me for fool.
mm milking the spread i tell ya... manipulation at it's finest and it's all sanctioned by the SEC.
if there were any intelligent life forms there; and discovered that board consisted of mostly jodi_buffet and ex14142000 patting each other on the back in an ill attempt to keep up morale as the SSH fills with water.
jodi and ex1414, this is the last time i'll be responding your idiotic posts b/c i have concluded that there's nothing to be gain from reading your insanity. don't bother responding, both of you have been added to my ignore list.
jodi, people jump jobs all the time so why would i care if some nobodies landed in SSH. there's nothing impressive about either brian or kim; their profiles reads just like any rank and file from a big company. how many VP's does a company like boston scientific and medtronic have? both of these companies have tens of thousands of employees... you do the math, and you'll see that these companies can easily have thousands of VP's... there's nothing special about these hires. now had an executive from either of these companies join SSH, i would then have consider it a positive.
having said that, only fools invest in a company based on management. a successful company needs both good managers and more importantly great science. SSH has neither. But what do i know, i'm just some nobody investor and i'm sure you SSH investors are much smarter than me so pay no attention to any of my nonsense.
so c-pulse pump was first implemented 11 years ago and it took another 5 years from then to start enrolling a proof of conjob trial in the usa (that didn't prove much since it had no control arm) and look at where it is now, another 5 years later; only starting to enrolling patients in it's us pivotal trial which will no doubt show that the pump either does not work or only works slightly better than placebo... you can take that to the bank. The fact that it took sooooo long for this gadget to make any progress is b/c the scientific community is not buying what sunshine is selling. why not? b/c the technology smells foul and these DOCTORS are too smart to fall for the scam unlike you idiot lottery chasing morons. you idiots are so dumb you have to go to another board to get you clocks cleaned. do continue to invest in ssh; in fact, you should bet the house on it. you and ssh deserve each other.
the data from c-pulse is from a study that did not have a control arm. on top of that, the small sample size makes it difficult to compare to historical data b/c there's a greater risk that these patients could just have been healthier than normal. b/c of this, it's impossible to say with any certainty that the treatment effect seen in the c-pulse trial was not due to the other treatments the patients were on. on top of that, even with the small sample size, there was a death and multiple infections related to c-pulse. so, c-pulse efficacy is still up in the air but it's safety concerns are already will documented. i've been investing in biotech for a long time so i've come across a lot foul smelling products that never panned out and c-pulse does not pass the smell test.
lol, swing is trading based on what he reads from seaking alpha. now that explains why he's always wrong. instead of doing his own DD (maybe he's incapable of doing so) he depends on articles written by any random schmuck on the street looking to push an agenda. since the article is full of statistics, than it must be true. haha, i guess swing never took statistics in college or he would know the saying "using statistics to lie". now i wonder, did swing even go to college?
these VCs pumped over 100 mil into celladon, and you expect us to think they are going to cash out on the cheap now that they are so close to getting pivotal data that could shoot the stock price well above a hundred. VCs don't take these kind of risk for a quick double. i would expect most if not all to wait until cupid 2 results are out b/f they make a move.
Serelaxin's rejection had NOTHING to do with breakthrough designation but instead on Novartis going for a hail mary approval based on questionable secondary endpoint of WHF. furthermore, their breakthrough designation was not in WHF but instead survival. So, their breakthrough designation only comes into play when they have pivotal data with survival as the primary endpoint which the didn't. if you continue to make wrong headed conclusions based on news headline, at some point, you're going to find yourself in a world of pain.
jodi, don't start putting the cart ahead of the horse.... c-pulse has not been approved by the fda and it's benefits (if any) have yet to be confirmed. the only clinical data is from a 20 patient single arm trial so we can't even say if benefits seen was b/c of c-pulse or other treatments the patients were also under. So, not only are we unsure if there are meaningful benefits from c-pulse, we observed that c-pulse has been associated with device related infections and death. One patient death from an aortic disruption was reported as a result of a re-sternotomy surgery to treat a procedure related infection. six exit site infections occurred and had to be treated with antibiotics. There was one instance of post operative, non-device related bleeding. with existing data, it's obvious to all without c-pulse blinders on that mydicar is multiple times quicker, simpler, cheaper, safer, and more effective (mydicar received breakthrough therapy designation).
those expecting c-pulse to be a slam dunk better wake up and smell the data b/c not only is there no evidence that it has any meaningful benefits, we have already observed incidence of death and infections related to the device or procedure.
tanto, you really believe momentum traders were driving up cldn price in absence of news? really? you need reread your trading for dummy book b/c you're still lacking in the abc's for biotech investing. needless to say, since you can't even get this right, everything else you said is equally foolish.
no need to worry swing,
you on the other hand better not hold you breath waiting for that sudden flood of shares or you will find yourself laying on the floor unconscious. either way, i'll do just fine since i don't day trade.
mydicar is currently not given to people with AAV1 NAb but that could all change if plasmapheresis becomes an option. Also, even if plasmapheresis is needed, this is just another outpatient procedure with no hospital stay. So, mydicar with plasmapheresis is still multiple times quicker, simpler, cheaper, and safer than C-pulse with or without the tube sticking out.
as for disconnecting the tube from the pump to take a shower, you better learn to take quick showers b/c you can only be disconnected for short periods of time. regardless of rather or not it's implanted, you better hope nothing goes wrong with the device or procedure b/c your life is now dependent on a foreign object working properly and being installed correctly -- who knows what can go wrong.
jodi, you have a lot to learn about people. how many sick patients would prefer to walk around with tubes sticking out of their body lugging around a purse size battery/pump 24/7. as oppose to an easy hassle free onetime outpatient procedure that could have them feeling much better without having to under go any surgery and home at the same day?
of course, there's a lot of different people out there and it wouldn't surprise me if some of them may actually think going under the knife and staying in the hospital for a few days to weeks is fun and get all giddy thinking of having tubes sticking out of their body and strapped to a pump as a great time. for these people, i'm sure they will jump at the opportunity of getting C-Pulse (this sounds right up your alley); however, for everyone else, mydicar would be the preferred option.
wrong again swing,
the 60% AAV1 NAb population is icing on a cake with a yearly market potential of 7 billion. yes, that's how much the 40% of AAV1 NAb negative population is worth if the price tag for mydicar is assume to be $20,000 (the expected cost of treating 1 case of heart failure). So, each additional AAV1 NAb patients they can treat by using plasmapheresis is another 20,000 added to the potential 7 billion market. idiots may see the need for plasmapheresis as a "major drawback" where as an experience biotech investor would see it as a HUGE opportunity on top of an already HUGE market.
as for the lock up expiration, only idiots would be concerned about this. the insiders will know best if cupid 1 data is real and if cupid 2 is trending positively and has a good chance of replicating cupid 1. So, if insiders are expecting good news from cupid 2 and expect mydicar approval, selling at the lock up expiration at these low prices will be the biggest financial blunder these insiders will ever make in their life. So, how many of these insiders who have been with the company for years will be willing to sell out their future for a few dollars come the end of july? I wouldn't hold your breath waiting for a flood of stocks by insiders anytime soon. At lease not until cupid 2 results are out if even then.